Drugs

Study New Guide on Science Info for MDs: Attorneys

Writing in National Law Review, three Epstein Becker Green attorneys say medical product manufacturers should study an FDA 2023 draft guidance on sharing scientific information with healthcare providers on unapproved uses of medical products “to mitigate potential risk in navigating the often murky regulatory waters of engaging in off-label and pre-approval communications.” The attorneys say the 2023 draft supersedes a 2014 draft that revised a 2009 final guidance.

All the guidances provide recommendations for the industry about communications to share scientific information on unapproved uses (SIUU). “In the 2023 guidance,” the attorneys write, “FDA seeks to balance the interests of HCPs in learning, and manufacturers in sharing, truthful and non-misleading information about unapproved uses of approved medical products…. While the 2023 draft guidance reiterates many of the recommendations from the 2014 draft guidance, the 2023 draft guidance leverages a new question-and-answer format to provide firms with more detailed and specific recommendations, including hypothetical scenarios, around SIUU communications.”

The article lists things firms should do and not do under these four questions:

the things firms should consider when determining whether a source publication is appropriate to serve as the basis for an SIUU communication;
the information that firms should include as part of SIUU communications;
the presentational considerations firms should take into account for SIUU communications; and
additional recommendations that apply to specific types of SIUU communications.

The attorneys say that companies that are complying with the 2014 draft guidance shouldn’t have too much difficulty in adjusting their activities to align with the new guidance.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome